ADA/Immunogenicity Data Handling

Hosted by the PKPD Programming Forum on Sep 9th, 2021.
The topic for discussion covers immunogenicity data in large molecule therapeutics from data collection, data handling, dataflow to data analysis and reporting. We would like to take this opportunity to give an overview of development of anti-drug antibody(ADA), interpretation of immunogenicity data, industry practices of structured data in raw SDTM and analysis datasets, and reporting of ADA impact to drug safety, drug efficacy and drug PK/PD.
presented by David Radtke and Jane Kang